Rehabilitation Program for Bladder Control in Individuals With Incomplete Spinal Cord Injury (BCSCI)

Cairo University (CU)

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Other: pelvic floor muscles training; Other: 1. IFC; Other: motor imagery training; Other: 2. Timed voiding.

Study type: Interventional

Funder types: Other

Identifiers

NCT07008157

PT.BU.EC.18

Details and patient eligibility

About

This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.

Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders.

Full description

This prospective, randomized, double-blind clinical trial (with both participants and outcome assessors blinded to group assignments) was carried out at the outpatient clinic of the Faculty of Physical Therapy, Cairo University, following patient referrals. Participants were recruited between October 2024 and April 2025 from the National Institute of Urology and Nephrology in Mataria, as well as the Department of Urology and Nephrology at Kasr Alaini Hospital. All diagnoses were verified by a consultant urologist. The study received ethical approval from the Institutional Review Board of the Faculty of Physical Therapy, Benha University, Egypt, and written informed consent was obtained from each participant prior to enrollment.

Participants Individuals between 18 and 65 years of age presenting with OAB symptoms, confirmed through urodynamic testing, and diagnosed with ISCI classified as AIS C or D above the L1 spinal level, were considered eligible for inclusion in this study. Participants were required to be medically stable, able to follow study protocols, and willing to provide informed consent. Exclusion criteria included those with complete spinal cord injury (AIS A), current urinary tract infections, a history of pelvic malignancy, prior bladder or pelvic surgeries, or significant cognitive or psychiatric disorders. Simple randomization was applied to allocate participants into one of two groups: the EG, which received IFC, PFMT, motor MIT, and timed voiding (TV); and the CG, which received IFC, PFMT, and TV. The randomization process involved a computer-generated sequence created using dedicated software to ensure an equal number of participants in each group. Allocation concealment was maintained by placing group assignments in sealed, opaque envelopes, which were opened sequentially as participants were enrolled in the study.

Outcome Measures

1. Urodynamic assessments

2. The International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF)

3. PFM strength Treatment procedures

4. IFC therapy 2. Timed voiding. 3. Motor imagery Training 4. PFMT

Enrollment: 74 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals between 18 and 65 years of age

  • presenting with OAB symptoms
  • diagnosed with ISCI classified as AIS C or D above the L1 spinal level

Exclusion criteria

• complete spinal cord injury
• current urinary tract infections
• a history of pelvic malignancy
• prior bladder or pelvic surgeries
• significant cognitive or psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

experimental group

Experimental group

Description:

received IFC, PFMT, motor MIT, and timed voiding (TV)1. IFC interferential current, pelvic floor muscles training, timed voiding, and motor imagery training

Treatment:

Other: 2. Timed voiding.

Other: motor imagery training

Other: 1. IFC

Other: pelvic floor muscles training

control group

Active Comparator group

Description:

participants received interferential current therapy, timed voiding, and pelvic floor muscles training

Treatment:

Other: 2. Timed voiding.

Other: 1. IFC

Other: pelvic floor muscles training